AbbVie Submits NDA in Japan for its Investigational, All-Oral, Treatment for Chronic Hepatitis C

AbbVie has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the company's investigational, all-oral, ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily. The submission is for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

The NDA is supported by the Phase III GIFT-I study, which met its primary endpoint, achieving a 95% (n=106/112) sustained virologic response rate at 12 weeks post-treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic, adult genotype 1b (GT1b)-infected Japanese patients who were eligible for therapy with IFN and had a high viral load (≥ 100,000 IU/mL). Additionally, two patients without cirrhosis (0.9%) discontinued treatment due to adverse events. GIFT-I included a placebo-controlled arm and studied patients with and without compensated cirrhosis, who were new to therapy or treatment-experienced (with IFN and with or without RBV).

"We are pleased to announce the regulatory submission of our two direct-acting hepatitis C antiviral treatment in Japan, which follows on quickly from recent approvals of our three direct-acting antiviral treatment in the US, Canada and the European Union," said Scott Brun, vice president, pharmaceutical development, AbbVie. "This submission is based on a large Phase III study in multiple patient types and brings us closer to offering the possibility of cure for patients with chronic genotype 1b hepatitis C infection, the most common form of the disease in the country."

AbbVie studied a two direct-acting antiviral regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b. In Japan, approximately 1.5–2 million people are living with HCV. Genotype 1 is the most common HCV genotype in Japan with 60–70% of patients infected and, of those, about 95% are infected with the GT1b sub-type.